MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAPLUSH - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CPL10020430
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is initial/final mdr being submitted for this complaint with associated mfr# 2954740-2017-00260.(b)(4).(b)(6).The device was damaged with no damages visible with the naked eye.The locking mechanism of the introducer sheath is not engaged with the resheathing tool and the clear tab of the introducer was retracted slightly proximal to the resheathing tool.The distal section embolic coil was compressed and kinked in the green introducer.There was also a kink at the proximal end of the embolic coil just past the articulating junction.The distal end of the embolic coil including the ball tip are intact with no evidence of damage.No damages to the introducer sheath were found.The device could not be advanced out of the green introducer and therefore could not be advanced through a microcatheter to test advancement.The complaint that the microcoil system could not be advanced through the proximal end of the microcatheter is confirmed.The device could not be advanced through its own introducer during testing.Unreported damage of coil kinking was observed.The circumstances of the coil kinking cannot be conclusively determined however as the complaint states that the device could not be advanced through the proximal shaft of the microcatheter it is likely that a source of unknown distal interference compressed and kinked the coil.These kinks in turn can cause the coil to push against the introducer wall and prevent it from advancing through the introducer.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Based on the information and the analysis, the reported event of resistance experienced was confirmed.The root cause of the failure could not be determined, however unreported coil kinking was found on the device during the analysis.This damage may have occurred due distal interference which likely caused the experienced resistance.Review of this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.There is no current safety signal identified related to the reported event based on review of complaint history for the device.
Event or Problem Description
As reported by a health care professional, during coiling of an anterior communicating artery aneurysm a deltaplush cerecyte 2 mm x 4 cm (cpl10020430/c38154) did not advance through the proximal shaft of a competitor¿s microcatheter (echelon14 45-degree mc).The procedure was continued using a same like product and a delay of 5 minutes was reported due to the product issue.A deltaplush and micrusphere coil went through the same mc without issues before and after the encountered resistance.There were no issues experienced with the echelon mc.There were no damages reported on the coil or the mc prior to use or upon removal.An adequate continuous flush was maintained through the catheter.There were no adverse consequences due to the reported event.It was initially reported that the complaint product is available for return, however the mc is not available for return.The deltaplush embolic coil was found to be kinked when received for investigation.It is unknown when the damage to the coil occurred.

• Brand Name: DELTAPLUSH - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6854294
• Report Number: 2954740-2017-00260
• Device Sequence Number: 801102
• Product Code: HCG
• UDI-Device Identifier: 00878528008224
• UDI-Public: (01)00878528008224(17)200831(10)C38154
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K083646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: CPL10020430
• Device Lot Number: C38154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2017
• Initial Report FDA Received Date: 09/11/2017
• Patient Sequence Number: 1